BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2830365 · Received November 13, 2012

    Report

    Report Number
    2955842-2012-00905
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI PROSTATECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE WIRES WERE EXPOSED ON THE PROGRASP FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120718 183

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES